Tramadol Hydrochloride
- Product NDC
- 53002-4321
- 11-digit product format
- 530024321
- Labeler code
- 53002
- Product ID
- 53002-4321_0540af6a-bdcd-4694-9dfd-6e96851ff6f4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRAMADOL HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA091498
- Marketing category
- ANDA
- Marketing start
- 2015-05-22
- Marketing end
- 0000-00-00
- Substance
- TRAMADOL HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53002-4321-1 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-e8ba-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, CIV Initial U.S. Approval: 1995 |
| 53002-4321-2 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-e8ba-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, CIV Initial U.S. Approval: 1995 |
| 53002-4321-3 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-e8ba-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, CIV Initial U.S. Approval: 1995 |
| 53002-4321-1 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d0-e8ba-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, CIV Initial U.S. Approval: 1995 |
| 53002-4321-2 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d0-e8ba-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, CIV Initial U.S. Approval: 1995 |
| 53002-4321-3 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d0-e8ba-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, CIV Initial U.S. Approval: 1995 |
| 53002-4321-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e8ba-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, CIV Initial U.S. Approval: 1995 |
| 53002-4321-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e8ba-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, CIV Initial U.S. Approval: 1995 |
| 53002-4321-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e8ba-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, CIV Initial U.S. Approval: 1995 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-4321-1 | Tramadol Hydrochloride | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 3 |
| 53002-4321-2 | Tramadol Hydrochloride | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 3 |
| 53002-4321-3 | Tramadol Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-4321 | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 3 package rows | 20201218_5f4105f7-be41-4863-8245-f39594672c65.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-4321-1 | 53002432101 | 10 TABLET, FILM COATED in 1 BOTTLE (53002-4321-1) | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-4321-2 | 53002432102 | 20 TABLET, FILM COATED in 1 BOTTLE (53002-4321-2) | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-4321-3 | 53002432103 | 30 TABLET, FILM COATED in 1 BOTTLE (53002-4321-3) | 2018-10-01 | 0000-00-00 | No | No | Current |